Trial Outcomes & Findings for Accuracy of Methemoglobin Measurement of Various Rainbow Pulse Oximeter Sensors (NCT NCT03124836)

Results Overview

Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.In order to obtain the Arms value, the blood sample methemoglobin value is subtracted from the pulse oximeter methemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

1-5 hours

Results posted on

2017-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	R2-25 Sensor All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor Pulse Oximeter Sensor
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accuracy of Methemoglobin Measurement of Various Rainbow Pulse Oximeter Sensors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	R2-25 Sensor n=28 Participants All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor Pulse Oximeter Sensor
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	10 Participants n=99 Participants
Sex: Female, Male Male	18 Participants n=99 Participants
Region of Enrollment United States	28 participants n=99 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.In order to obtain the Arms value, the blood sample methemoglobin value is subtracted from the pulse oximeter methemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Outcome measures

Outcome measures
Measure	R2-25 Sensor n=28 Participants All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor Pulse Oximeter Sensor
Accuracy of Methemoglobin Measurement by Arms Calculation	0.48 percentage of total hemoglobin

Adverse Events

R2-25 Sensor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vikram Ramakanth

Masimo

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60